A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: placebo

Drug: insulin 338 (GIPET I)

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01796366

2012-003046-32 (EudraCT Number)

NN1953-4013

U1111-1132-0943 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.

Enrollment

40 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)
Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more

Exclusion criteria

Known or suspected hypersensitivity to trial products or related products
Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator
Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol